On October 4, he FDA announced that H&H Medical Corporation intiated a nationwide recall of 6,619 units of the H&H Emergency Cricothyrotomy Kit. The product has been found to show the potential for a defective cuff balloon on the provided endotracheal airway. Consumers who have this product should stop using the product and return them to their original place of purchase for immediate credit. Distributors are instructed to return all recalled items meeting the lot numbers listed below for return credit or for immediate replacement. The cuff balloon may be defective due to a very particular set of circumstances (a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping used to shield the cuff balloon at the end of the endotracheal airway). To date, no injuries or deaths have been reported to H&H or to the FDA. H&H Medical Corporation is notifying its distributors and customers by letter and email as well as posting this notice on our website at http://www.gohandh.com. Users should quarantine this product from inventory and return it to the original source of sale for credit or to request immediate replacement. Distributors and resellers are to return recalled product to H&H by contacting Michelle Morgan at 804-642-3663 or by email at [email protected]. Please indicate whether replacement kits or purchase credit is requested. All return shipping costs will be paid by H&H Medical Corporation. H&H Medical Corporation distributed this product within the Continental United States, primarily for U.S. military sale and use. Consumers with questions may contact H&H Medical Corporation via telephone at 800-326-5708 between the hours of 8 a.m. and 4:30 p.m. (Eastern Time Zone). Consumer may also contact the company via e-mail at [email protected]. To learn more about this recall, visit the FDA website. Contact us 24/7.
Written by Andrew Finkelstein | Last Updated: June 17, 2021